DUTASTERIDE/TAMSULOSIN ARISTO 0.5 mg/0.4 mg HARD CAPSULES

Introduction

Patient Information Leaflet

Dutasteride/Tamsulosin Aristo 0.5 mg/0.4 mg hard capsules EFG

Dutasteride/Tamsulosin Hydrochloride

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Dutasteride/Tamsulosin Aristo and what is it used for
2. What you need to know before you take Dutasteride/Tamsulosin Aristo
3. How to take Dutasteride/Tamsulosin Aristo
4. Possible side effects
5. Storing Dutasteride/Tamsulosin Aristo
6. Contents of the pack and other information

1. What is Dutasteride/Tamsulosin Aristo and what is it used for

This medicineis used in men to treat an enlarged prostate(benign prostatic hyperplasia) - a non-cancerous growth of the prostate caused by overproduction of a hormone called dihydrotestosterone.

Dutasteride/Tamsulosin Aristo is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitorsand tamsulosin belongs to a group of medicines called alpha blockers.

As the prostate grows, it can cause urinary problems such as difficulty in the flow of urine and a need to urinate more frequently. It can also cause the stream of urine to be weaker and less forceful. If left untreated, benign prostatic hyperplasia can lead to a risk of the urine flow being completely blocked (acute urinary retention). This requires immediate medical treatment. In some cases, surgery may be necessary to reduce the size of the prostate or remove it.

Dutasteride reduces the production of dihydrotestosterone, which helps to reduce the size of the prostate and relieve symptoms. This reduces the risk of acute urinary retention and the need for surgery. Tamsulosin works by relaxing the muscles in the prostate, making it easier to urinate and quickly improving symptoms.

2. What you need to know before you take Dutasteride/Tamsulosin Aristo

Do not take dutasteride/tamsulosin:

• if you are a woman(because this medicine is only for men)
• if you are a child or adolescent under 18 years of age
• if you are allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soy, peanutor any of the other ingredients of this medicine (listed in section 6)
• if you have low blood pressure, which makes you feel dizzy, lightheaded or faint (orthostatic hypotension)
• if you have severe liver disease.

If you think you may have any of these conditions, do not takethis medicine until you have consulted your doctor.

Warnings and precautions

Talk to your doctor before starting to take dutasteride/tamsulosin.

• In some clinical studies, there was a higher number of patients taking dutasteride and another medicine called an alpha blocker, such as tamsulosin, who experienced heart failure compared to patients who took only dutasteride or only an alpha blocker. Heart failure means that your heart does not pump blood as it should.

• Make sure your doctor knows if you have liver problems. If you have any disease that affects your liver, you may need some additional checks during your treatment with dutasteride/tamsulosin.

• Make sure your doctor knows if you have severe kidney problems.

• Cataract surgery (cloudy lens). If you are going to have cataract surgery, your doctor may ask you to stop taking dutasteride/tamsulosin for a while before the operation. Before the operation, tell your eye specialist that you are taking dutasteride/tamsulosin or tamsulosin (or if you have taken them in the past). Your specialist will need to take the necessary precautions to avoid complications during the operation.

• Women, children, and adolescentsshould avoid contact with broken dutasteride/tamsulosin capsules, as the active ingredient can be absorbed through the skin. If there is any contact with the skin, wash the affected area immediatelywith water and soap.

• Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen, as dutasteride may affect the normal development of a male baby. Dutasteride causes a decrease in sperm count, motility, and semen volume. This may reduce fertility.

• Dutasteride/tamsulosin affects the PSA blood test(prostate-specific antigen) that is sometimes used to detect prostate cancer. Your doctor may still use this test to detect prostate cancer, although they should be aware of this effect. If you have a blood test to check your PSA, tell your doctor that you are taking dutasteride/tamsulosin.

Men taking dutasteride/tamsulosin should have regular PSA checks.

• In a clinical study in men at high risk of prostate cancer, men who took dutasteride had a higher incidence of high-grade prostate cancer than those who did not take dutasteride. The effect of dutasteride on this type of high-grade prostate cancer is not clear.

• Dutasteride/tamsulosin may cause breast enlargement and pain. If this causes you discomfort, or if you notice lumps in your breast or nipple discharge, consult your doctor, as these changes can be signs of a serious disease, such as breast cancer.

If you have any questions related to taking dutasteride/tamsulosin, ask your doctor or pharmacist.

Using dutasteride/tamsulosin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take dutasteride/tamsulosin with these medicines:

• other alpha blockers(for enlarged prostate or high blood pressure).

It is not recommended to take dutasteride/tamsulosin with these medicines:

• ketoconazole(used to treat fungal infections).

Certain medicines may interact with dutasteride/tamsulosin, which may increase the risk of you experiencing side effects. Some of these medicines are:

• PDE5 inhibitors(used to achieve or maintain an erection) such as vardenafil, sildenafil citrate, and tadalafil
• verapamil or diltiazem(for high blood pressure)
• ritonavir or indinavir(for AIDS)
• itraconazole or ketoconazole(for fungal infections)
• nefazodone(an antidepressant)
• cimetidine(for stomach ulcers)
• warfarin(for blood clotting)
• erythromycin(an antibiotic used to treat infections)
• paroxetine(an antidepressant)
• terbinafine(used to treat fungal infections)
• diclofenac(used to treat pain and inflammation).

Tell your doctorif you are taking any of these medicines.

Taking Dutasteride/Tamsulosin Aristo with food and drinks

You should take dutasteride/tamsulosin 30 minutes after the same meal each day.

Pregnancy, breastfeeding, and fertility

Women should not takedutasteride/tamsulosin.

Pregnant women (or women who may be pregnant) should avoid contact with broken capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male baby. This risk is especially important during the first 16 weeks of pregnancy.

If a pregnant woman has been in contact with dutasteride/tamsulosin, consult a doctor.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking dutasteride/tamsulosin. If your partner is pregnant or thinks she may be pregnant, she should avoid exposure to your semen.

Dutasteride/tamsulosin has been shown to decrease sperm count, motility, and semen volume. This may reduce fertility.

Driving and using machines

Some people may experience dizziness during treatment with dutasteride/tamsulosin, which may affect their ability to drive or operate machinery safely.

Do not drive or operate machineryif you are affected in this way.

This medicine containsorange yellow S (E110), soy lecithin, and sodium.

It may cause allergic reactions because it contains orange yellow S (E110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Dutasteride/Tamsulosin Aristo contains soy lecithin. It should not be used in case of peanut or soy allergy.

This medicine contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Dutasteride/Tamsulosin Aristo

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you do not take dutasteride/tamsulosin regularly, the control of your PSA levels may be affected. If in doubt, consult your doctor or pharmacist again.

What dose should you take

The recommended dose is one capsule once a day, 30 minutes after the same meal each day.

How to take it

The capsules should be swallowed whole, with water. Do not chew or open the capsules. Contact with the contents of the capsules can irritate your mouth or throat.

If you take more dutasteride/tamsulosin than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take dutasteride/tamsulosin

Do not take a double dose to make up for forgotten doses. Take the next dose at the usual time.

Do not stop taking dutasteride/tamsulosin without advice

Do not stop taking dutasteride/tamsulosin without consulting your doctor first.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Allergic reaction

Symptoms of an allergic reaction can include:

• skin rash (which can itch)
• hives (like nettle rash)
• swelling of the eyelids, face, lips, arms, or legs

Contact your doctor immediatelyif you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Dizziness, lightheadedness, and fainting

Dutasteride/tamsulosin can cause dizziness, lightheadedness, and, in rare cases, fainting. You should be careful when getting up quickly after sitting or lying down, especially if you need to get up during the night, until you know how this medicine affects you. If you feel dizzy or lightheaded during treatment, sit or lie down until these symptoms have disappeared.

Severe skin reactions

Signs of severe skin reactions can include:

• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals(Stevens-Johnson syndrome)

Contact your doctor immediatelyif you experience any of these symptoms and stop taking dutasteride/tamsulosin.

Common side effects(may affect up to 1 in 10 patients):

• impotence (inability to achieve or maintain an erection)*
• decreased sex drive (libido)*
• difficulty with ejaculation, such as a decrease in the amount of semen released during sex*
• breast enlargement and pain (gynaecomastia)
• dizziness

• In a small number of people, some of these side effects may continue after stopping dutasteride/tamsulosin.

Uncommon side effects(may affect up to 1 in 100 patients):

• heart failure (the heart becomes less efficient at pumping blood around the body. This could cause symptoms such as difficulty breathing, excessive tiredness, and swelling in the ankles and legs)
• reduction in blood pressure when standing up
• fast heart rate (palpitations)
• constipation, diarrhea, vomiting, nausea
• weakness or loss of strength
• headache
• itching, stuffy or runny nose (rhinitis)
• skin rash, hives, itching
• hair loss (usually from the body) or excessive hair growth

Rare side effects(may affect up to 1 in 1,000 patients):

• swelling of the eyelids, face, lips, arms, or legs (angioedema)
• fainting

Very rare side effects(may affect up to 1 in 10,000 patients):

• prolonged and painful erection of the penis (priapism)
• severe skin reactions (Stevens-Johnson syndrome)

Other side effects

Other side effects have been reported in a small number of patients, but their frequency is not known (the frequency cannot be estimated from the available data):

• abnormal or rapid heart rhythm (arrhythmia or tachycardia or atrial fibrillation)
• difficulty breathing (dyspnoea)
• depression
• pain and swelling in the testicles
• nosebleeds
• severe skin rash
• changes in vision (blurred vision or visual problems)
• dry mouth

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Dutasteride/Tamsulosin Aristo

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused capsules to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Dutasterida/Tamsulosina Aristo

• The active ingredients are dutasteride and tamsulosin hydrochloride. Each capsule contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.

• The other components are:

• hard capsule shell:hypromellose, carrageenan (E407), potassium chloride, titanium dioxide (E171), red iron oxide (E172), orange yellow S (E110).

• inside the hard capsule:glycerol monocaprylocaprate (Type I), butylhydroxytoluene (E321), gelatin, glycerol, titanium dioxide (E171), yellow iron oxide (E172), medium-chain triglycerides, soy lecithin (may contain soybean oil) (E322), microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, methacrylic acid-ethyl acrylate copolymer (1:1), magnesium stearate, sodium hydroxide, triacetin, talc, titanium dioxide (E171).

Appearance of the Product and Container Content

This medication is presented in hard, oblong capsules, with an approximate length of 24 mm, with a brown body and an orange cap.

It is available in packs of 9, 30, and 90 capsules, in aluminum/aluminum blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer:

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36,

San Agustín de Guadalix,

28750, Madrid, Spain.

or

Galenicum Health S.L.U.

Calle Sant Gabriel, 50,

Esplugues de Llobregat,

08950, Barcelona, Spain.

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Malta Dutasteride/Tamsulosin Aristo 0.5 mg/0.4 mg hard capsules

Czech Republic Marumax 0.5 mg/0.4 mg tvrdé tobolky

Germany Dutalosin 0.5 mg/0.4 mg Hartkapseln

Italy Dutasteride and Tamsulosina Aristo 0.5 mg/0.4 mg capsule rigide

Portugal Dutasterida/Tansulosina Aristo 0.5 mg/0.4 mg cápsula

Poland Marumax 0.5 mg + 0.4 mg kapsulki twarde

Spain Dutasterida/Tamsulosina Aristo 0.5 mg/0.4 mg cápsula duras

United Kingdom Dutasteride/Tamsulosin hydrochloride 0.5 mg/0.4 mg hard capsules

Date of the Last Revision of this Prospectus: February 2020.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es